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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	5 April 2021
Main ID:	EUCTR2008-004278-41-BE
Date of registration:	08/07/2008
Prospective Registration:	Yes
Primary sponsor:	Institut Jules Bordet
Public title:	A phase II study of doxorubicin, cyclophosphamide and vindesine with valproic acid in patients with refractory or relapsing small cell lung cancer after platinum derivatives and etoposide.
Scientific title:	A phase II study of doxorubicin, cyclophosphamide and vindesine with valproic acid in patients with refractory or relapsing small cell lung cancer after platinum derivatives and etoposide.
Date of first enrolment:	19/04/2010
Target sample size:	43
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004278-41
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
Belgium

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- Histological or cytological diagnosis of small-cell lung cancer (SCLC)
- SCLC refractory to prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) and etoposide, either primary refractory (immediate progression or recurrence less than 3 months after the end of previous chemotherapy) or secondary refractory (sensitive patients to platinum plus etoposide in first-line, progressing or recurring less than 3 months after reintroduction of the same chemotherapy).
- At least one evaluable or measurable lesion
- Availability for participating in the detailed follow-up of the protocol
- Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Patient who were previously treated with anthracyclin or vinca-alcaloid derivatives or cyclophosphamide
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
- A history of prior HIV infection
- Polynuclear cells < 2,000/mm³
- Platelet cells < 100,000/mm³
- Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
- Serum bilirubin >1.5 mg/100 ml
- Transaminases more than twice the normal range
- Serum creatinine > 1.5 mg/100 ml
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure (ejection fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia
- Uncontrolled infectious disease
- Active epilepsy needing a specific treatment
- Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
- Pregnancy or refusal to use active contraception
- A known allergy to valproic acid and/or doxorubicin, cyclophosphamide, vindesine
- Serious medical or psychological factors which may prevent adherence to the treatment schedule.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

This is a prospective phase II study investigating well-known chemotherapeutic (doxorubicin, cyclophosphamide, vindesine) and antiepileptic (valproate) agents, in combination, for the treatment of refractory or recurrent small cell lung carcinoma after platinum derivatives and etoposide, for which no standard treatment is available in this indication.

Intervention(s)

Product Name: Doxorubicin
Product Code: Doxorubicin
Pharmaceutical Form: Intravenous infusion
Other descriptive name: Doxorubicin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 45-

Product Name: Cyclophosphamide
Product Code: Cyclophosphamide
Pharmaceutical Form: Intravenous infusion
Other descriptive name: cyclophosphamide
Concentration unit: gm/m2 gram(s)/square meter
Concentration type: equal
Concentration number: 1-

Product Name: Vindesine
Product Code: Vindesine
Pharmaceutical Form: Intravenous infusion
Other descriptive name: vindesine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 3-

Product Name: Valproate
Product Code: Valproate
Pharmaceutical Form: Modified-release capsule, hard
Other descriptive name: Depakine
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 20-30

Primary Outcome(s)

Secondary Objective: - to determine overall survival of the combination of VdsAC plus valproic acid
- to determine response rate of the combination of VdsAC plus valproic acid
- to assess the toxicity of the combination of VdsAC plus valproic acid
- to assess HDAC activity in blood peripheral lymphocytes in patients treated with VdsAC plus valproic acid
- to assess new potential blood and tissue markers of lung cancer pathogenesis or prognosis (endocan, VEGF, VEGF-R2, CCL18, ADAMs, …) in patients treated with VdsAC plus valproic acid

Primary end point(s): To determine 6 months progression-free survival of the combination of doxorubicin, cyclophosphamide and vindesine (VdsAC) plus valproic acid in patients with refractory SCLC after treatment with platinum derivatives, cisplatin or carboplatin, and etoposide

Main Objective: To determine 6 months progression-free survival of the combination of doxorubicin, cyclophosphamide and vindesine (VdsAC) plus valproic acid in patients with refractory SCLC after treatment with platinum derivatives, cisplatin or carboplatin, and etoposide.

Secondary Outcome(s)

Secondary ID(s)

01081

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 19/04/2010
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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